Reading Time: <1 minuteMany patients visit our hospital after undergoing MiraDry treatment with no results and wanting retreatment. 10 years ago, they underwent MiraDry treatment and the condition recurred... XNUMX years ago, they underwent the double pass method... but it was less effective than XNUMX years ago... When MiraDry was first introduced, doctors were in charge of treatment, but recently, most medical institutions have started to use nurses to perform treatment. Naturally, you cannot expect results if you receive treatment from a nurse. (As I have repeatedly stated in this blog before, if there is evidence of the effectiveness and safety of nurse treatment, please contact our hospital if you are the nurse in charge. We are always happy to listen to your story and discuss it. Of course, doctors who have nurses perform treatment as well) This is not only due to the lack of experience of doctors in treating underarm odor, but also due to price competition, the quality of treatment is significantly reduced, and labor costs are reduced by having nurses with no knowledge of underarm odor perform the treatment... Effective results cannot be expected from nurse treatment. Proper medical care is when a specialist with knowledge and experience takes responsibility for treating the patient to the end. There are patients who have been deceived by the MiraDry business, paying large sums of money for repeated treatments, wasting a lot of pain and time. The result was that only burn scars remained and there was no effect at all. It is very unfortunate. Recently, there are many medical institutions that boldly advertise that "MiraDry is the only medical device in Japan approved by the Ministry of Health, Labor and Welfare to treat underarm odor and hyperhidrosis. Since strict screening and a large number of cases are required to obtain approval from the Ministry of Health, Labor and Welfare, approved devices can be said to be medical devices with a high level of safety." Is this statement true?
It's false! Don't be fooled!
<Approval conditions (draft)> https://www.pmda.go.jp/medical_devices/2018/M20180611001/340679000_23000BZX00161000_A100_1.pdf
Necessary measures must be taken to ensure that doctors with sufficient knowledge related to the treatment of primary localized hyperhidrosis use this product in accordance with its intended purpose and method of use, after having fully acquired knowledge of the skills and complications associated with the procedure regarding the use of this product. First of all, it is not a medical device to be sold to nurses. It is a medical device that has been approved with a safety setting proposal on the condition that it is used by doctors. If a nurse performs MiraDry, it cannot be said to be safe. Moreover, it is a medical device that is only intended for severe primary axillary hyperhidrosis, that is, a disease that causes excessive sweating, and is not a medical device approved by the Ministry of Health, Labor and Welfare for the treatment of the so-called odor... armpit odor.
It is hard to imagine that a medical institution that attracts customers with such false slogans is providing legitimate and safe underarm odor treatment.
https://www.mhlw.go.jp/stf/shingi2/0000200760_00004.html
→ As a result of the clinical trial, the criteria for odor could not be met, so overall, the product is only approved for use in treating hyperhidrosis.The review concluded that the odor reduction effect was not observed.○Kitazawa Committee Member: I understand some of the information you have just given, but is this for people who sweat a lot, and is it correct that it is not suitable for people with underarm odor? ○Pharmaceuticals and Medical Devices Agency: As you have pointed out, this product is only suitable for patients with primary axillary hyperhidrosis, and of course,Not suitable for patients with axillary odor○ Pharmaceuticals and Medical Devices Agency I think that there are many patients who suffer from both hyperhidrosis and axillary odor at the same time. However, in principle, the sweat glands that cause hyperhidrosis are eccrine sweat glands, while the sweat glands that cause axillary odor are apocrine sweat glands, so the sweat glands that cause the sweat glands are different in the first place. The target of this device is the eccrine sweat glands, so the results of this clinical trial showed that it is effective only for hyperhidrosis. In terms of indications, we have determined that it is more appropriate to use it only for hyperhidrosis.
The effectiveness of MiraDry against underarm odor has not been proven, and it is clear that it has not been approved by the Ministry of Health, Labor and Welfare as a device for treating underarm odor.
We hope that the number of patients suffering from Nurse MiraDry treatment will not increase any further.